October 2012 | Vol. 8, Issue #3
Quality Assessment Monitors
The previous two issues of this year’s Management
Bulletin have discussed the basic principles of Quality
Assessment (QA) and how to organize a QA team. In
this issue, we will discuss how to select and
implement monitors or quality indicators that will
assess the laboratory’s quality systems. For a
laboratory to have an effective and efficient QA plan,
it must first identify the key aspects of the
laboratory’s performance and services that warrant
ongoing monitoring. Some monitors are required by
regulatory agencies, some are known “problem”
areas, and some quality indicators are monitored
because they are critical steps in a process. Most
importantly, the laboratory must choose various
indicators that monitor all phases of the total testing
process as well as the general laboratory system.
Why Monitor the Laboratory Quality
Systems
The main goal of a laboratory’s QA program is to
prevent errors before they occur. Monitoring key
quality indicators allows management and the QA
team to identify where errors are occurring or have
the potential to occur. The team can focus their
attention to these areas to develop a corrective
action plan that will result in quality improvement.
Monitoring the laboratory quality systems is a
requirement of regulatory agencies, accrediting
organizations and contractual arrangements. The
Clinical Laboratory Improvement Amendments
(CLIA) ’88 § 493.1200 states: Each laboratory that
performs nonwaived testing must establish and
maintain written policies and procedures that
implement and monitor a quality systems for all
phases of the total testing process (that is,
preanalytic, analytic, and postanalytic) as well as
general laboratory systems.
(b) The laboratory’s quality systems must include a
quality assessment component that ensures
continuous improvement of the laboratory’s
performance and services through ongoing
monitoring that identifies, evaluates and resolves
problems.
The North Carolina State Laboratory of Public Health
(NCSLPH) CLIA Contract Program states that: “The
laboratory must establish and maintain a written QA
plan that provides an ongoing mechanism for
monitoring and assessing laboratory activities. …”
The key word is “monitor” which means to measure
and to assess. Monitoring is simply a way for the
laboratory to quantify how well they are performing
by measuring specific quality indicators that are
designed to detect errors or potential errors in a
process. That is why it is critical for the laboratory to
customize and choose key quality indicators that
monitor the integrity of the entire testing process.
Selecting What Quality Indicators to
Monitor
As previously stated, quality indicators can be
designed to measure any aspect of the laboratory
quality systems. When the QA team is deciding what
quality indicators to monitor, it should evaluate
where the laboratory is at the highest risk for
potential errors to occur. It should also look at steps
in processes to determine which are most critical. A
critical step is a step that, if missed or incorrectly
performed, has the potential to cause harm or even
death to a patient or employee.
An indicator should be well defined, practical and
have a realistic action threshold. It should provide
valuable information that leads to change and
continuous improvement.
Poorly designed
indicators or continuously monitoring an indicator
that has been determined as stable is not only a
waste of valuable time and resources, but can also
result in confusing or misleading information. Below
is a list of examples of quality indicators that a
laboratory could choose to monitor.
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Preanalytic process indicators:
Patient identification.
Completeness and accuracy of
sample requisitions/orders.
Sample collection and labeling.
Sample storage and transport.
Analytic process indicators:
QC performance and corrective
actions.
Instrument comparisons.
PT performance and corrective
actions.
Postanalytic process indicators:
Complete and accurate test
reports.
Critical value reporting.
Stat turnaround time.
General Laboratory System:
Complaint investigation.
Personnel competency.
Personnel safety.
Selecting good quality indicators to monitor is the
first step in developing a well-defined QA plan. Next,
the QA team will need to determine action
thresholds or target values.
Determining Action Thresholds or
Target Values
An action threshold or target value simply states
“what are we trying to accomplish?” and “when do
we need to take action?” It is, in most cases, a
numerical value assigned to a quality indicator that,
when exceeded, indicates that a process is failing
and the laboratory needs to take further action and
investigate why it is failing.
When establishing an action threshold or target
value, the laboratory must determine the feasibility
of the target and whether it actually improves the
quality of patient safety, patient care or laboratory
service. For example, a laboratory implements in
their QA plan that 100% of all patients will be
correctly identified. Is this action threshold feasible
and does it improve the quality of patient care and/
or safety? Absolutely! Correctly identifying a patient
is a critical step in the preanalytic process. One
patient identification error could result in patient
harm or in worst case scenario, death.
Once the team has assigned action thresholds or
target values to the selected indicators, the next
step is to determine how the information will be
collected.
Collection of the Data
How frequently should a lab monitor its quality
indicators? CLIA recommends at least once a year. Is
this always sufficient? Yes, no, maybe. The lab will
need to review data to determine if the indicator is a
known “problem” area, a critical step in a process
that needs constant monitoring, or a relatively stable
indicator that requires only periodic monitoring.
Once frequency has been determined, the team will
need to determine how the data will be collected.
The team must decide what tools they will use to
collect the data. They can develop forms, checklists
or logs that would aid in the collection of the data.
In larger facilities, computer programs or document
control systems can be purchased that collect,
evaluate and report the data. Once the team decides
which tool(s) will be used to collect the information,
they will need to designate a person who will be
responsible for performing the monitor.
The person that the team selects to perform the
monitor should be someone who has an
understanding of how the laboratory functions and
is able to collect and present the data without
bias. The data collected should not be presented
in a negative context, nor should the data be
purposely skewed to make it appear that the lab
is performing better than it is. Instead, should be
presented in a way that is both educational and
informative. The information collected should be
viewed as a positive way for the laboratory to
take an internal look at itself to see what is
working and what is not working.
The overall goal of QA is to ensure that the
laboratory is always in a state of continuous
quality improvement. Once the information has
been collected, it will need to be evaluated to
see what corrective action, if any, needs to be
taken to improve the process
When to Take Action
The data must be evaluated to see what type of
action will need to be taken. The team will need
to decide if a QA study is required or if the data
reveals a problem that is just developing?
When should a QA study be initiated? When a
significant problem or error has been identified,
then it is necessary to initiate a QA study. How
do we determine if an error or problem is
significant? A problem or error is significant
when the lab is performing well below its
established action threshold or the problem is
widespread, trending, reoccurring or the error
has the potential to cause harm or has caused
harm to a patient or employee.
In some cases the data may indicate that there is
a problem developing. In this case, the team
may not need to initiate a formal QA study, but
may need to document that this indicator will be
monitored more frequently to see if a trend is
developing.
Once it has been determined what action is
required, the team must document the action plan
in its entirety.
Document, Document, Document!
Documentation is crucial in the QA monitoring
process. The first questions that an inspector will ask
are, “Do you have documentation that your lab
monitors it’s quality systems?” and “Do you have
documentation of what corrective action and followup was taken when errors were detected?”
The QA team will need to document the findings of
the investigation when a problem or error was
detected during monitoring. They will need to
document the plan of action that was implemented
to improve the process. And last but not least, the
team will need to document its plan for follow-up.
This should include a timeframe for the indicator to
be reassessed to see if the plan of action was
effective.
Without documentation, the laboratory does not
have evidence to prove that they have implemented
a QA plan that effectively monitors and assesses the
laboratory’s quality systems.
Communication
It is vital that the team communicates the outcome
to all individuals involved in the QA process to
include lab staff and the facility. In cases where the
plan was not effective, soliciting feedback will afford
everyone an opportunity to suggest ideas on how to
improve the process.
QA is everyone’s responsibility.
Summary
Developing key quality indicators that monitor the
integrity of the laboratory quality system is essential
in developing an effective and efficient
QA plan. On-going monitoring, improving
processes, follow-up and communication are
all integral parts of a well-defined QA plan that
is committed to continuous quality
improvement.
April Hill, MLS (ASCP) cm
References:
1. Federal Register 42 CFR Part 493 Clinical
Laboratory Improvement Amendments
(CLIA) (Accessed August, 2012)
2. Sharon S. Ehrmeyer, Ph.D. ,Westgard QC,
Inc., 2012, The New Poor Lab’s Guide to
the Regulations.
3. Clinical and Laboratory Standard Institute,
2010, GP35-A Development and Use of
Quality Indicators for Process
Improvement and Monitoring of
Laboratory Quality; Approved Guidelines.
4. LABMEDICINE, Volume 39 number 2,
February 2008, Benchmarking Laboratory
Quality. (Accessed August 2012)
5. Lab Medicine, 2010, Evaluating Laboratory
Performance with Quality Indicators. ,
(Accessed August 9,2012)
6. April Hill, Quality Assessment Study,
January 20, 2012.